Device for connecting hollow organs, especially blood vessels, by surgery

ABSTRACT

A sleeve for enforcing the end of a hollow organ so that it can be connected with a further end of a hollow organ, the sleeve comprising a cylindrical shape and being configured to be pushed over the end of the hollow organ and for turning-over the end of the hollow organ projecting from the sleeve around an end of the sleeve, wherein the sleeve has an adjustable diameter.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.13/972,452, filed on Aug. 21, 2013, which is incorporated herein byreference in its entirety.

FIELD OF THE INVENTION

The invention relates to a device for the anastomosis of hollow organs.

BACKGROUND OF THE INVENTION

One important task in surgery is end-to-end anastomosis. In the textwhich follows, this should be understood to mean in particular thesurgical connection of blood vessels. However, the techniques describedbelow can in principle also be used for the anastomosis of any holloworgan ends.

In end-to-end anastomosis, stitching is the most frequently usedconnection technique. However, instead of stitching, which takes a lotof time, the connection can also be achieved in a fraction of the timeby using fittings and sleeves. For this purpose, a sleeve which ispreferably biodegradable is pushed over each of the two vessel ends. Theinner diameter of said sleeve must correspond approximately to the outerdiameter of the vessels. The sleeve is in each case pushed over thevessel until the end of the vessel protrudes slightly out of the sleeve.The end of the vessel then has to be turned over around the end of thesleeve so that the sleeve is secured and the inner side of the vessel,the tunica intima, is facing outwards. The two sleeves are then pushedinto a third fitting and are fixed in the latter in such a way that theinner sides of the two vessels make contact with one another around theentire circumference. This is necessary in order for the two vessel endsto be able to grow together.

During this procedure, the work of the surgeon can be facilitated byvarious auxiliary means, for example by using devices which hold andclamp the ends of the blood vessels, which hold fittings and help toalign these with one another in the axial direction, which make iteasier to push the fittings together, or by using a device which assistsand facilitates the process of turning the ends of the blood vesselsover around the ends of the fittings.

Many auxiliary means for the anastomosis of vessels have already beenknown for decades. U.S. Pat. Nos. 4,474,181 and 4,624,255 disclose adevice which consists essentially of a ring having a diameter largerthan the outer diameter of the blood vessel. The vessel ends to beconnected are firstly stitched together at least at three points. Thering is then pushed over the stitching area. Using the threads of thestitches, the vessel is widened to the diameter of the ring and is fixedto the ring in this position. As a result, the inner sides of the twovessels are brought into contact with one another. U.S. Pat. Nos.4,016,883 and 4,165,747 contain examples of clamps, especially for bloodvessels having a small diameter. U.S. Pat. No. 4,165,747 moreoverproposes clamps which are arranged in a displaceable manner on a commonrail. In this way, the blood vessels can be simultaneously clamped andcan be fixed in position relative to one another; this makes it easierto stitch them together.

Further devices which ensure the mutual axial alignment of the vesselends and fittings are described in U.S. Pat. Nos. 1,151,300, 2,940,451and 3,048,177. In all cases, at least one vessel end must be turned overaround a sleeve prior to the connection operation so that the innersides of the two vessels make contact with one another after beingjoined.

Unlike the abovementioned patent specifications, U.S. Pat. No. 2,453,056describes how the turning-over of the vessel ends is achieved, namely byusing tweezers. It is known that it is very difficult to turn vesselsover using a number of pairs of tweezers, and this process sometimesrequires more than one person. Even if the surgeon is assisted by amechanical device which is able to hold and guide a number of pairs oftweezers or grippers in a suitable manner, there is still the risk thatthe vessel ends will be damaged during the manipulations.

U.S. Pat. No. 2,453,056 demonstrates that the use of sleeves or fittingsas auxiliary means for anastomosis has already been known for a verylong time. U.S. Pat. Nos. 3,221,746, 3,254,650, 3,254,651, 3,774,615,4,366,819 or U.S. Patent Appl. Publ. No. 2004/0199189 A1 also proposethe use of fittings. However, a difficulty using sleeves and fittings isthat basically for each hollow organ a specific sleeve and fitting hasto be provided with diameters corresponding to the hollow organ it isused with.

Various auxiliary means have also been developed for turning the vesselends over around the end of a sleeve. GB 1413191 proposes a number ofspikes which are formed on the outside of the sleeve and can be moved inthe axial direction. They have barbs pointing outwards and protrudeslightly beyond the end of the sleeve. The edge of the vessel, which haspreviously been pushed through the sleeve, is pulled and respectivelypushed onto the barbs by means of tweezers. The spikes are thenretracted. The vessel end is thus pulled over the end of the sleeve.

U.S. Pat. No. 2,940,452 proposes the use of an elastomer membrane. Thelatter is pulled taut over the end of a tube. A cylindrical piston witha conical end is then pushed forward through the interior of the tubeuntil the membrane has a conical bulge. In this position, the pistonwith the membrane pulled taut over it is pushed into the end of theblood vessel protruding beyond a sleeve and then is pressed against thesleeve. The outer tube is then pushed in the direction of the vessel. Inthe process, the membrane is placed around the end of the sleeve, andwith it the protruding part of the blood vessel.

U.S. Pat. No. 3,180,337 describes a similar device, but without themembrane. A cylindrical piston with a conical end is again used. Thecylindrical part of the piston is surrounded by an axially displaceabletubular part made of elastic material. Firstly, the conical end of thepiston is pushed into the end of the blood vessel protruding beyond asleeve and then is pressed against the sleeve. The aforementionedtubular piece is then pushed over the piston in the direction of theblood vessel. The tubular piece firstly upsets the protruding end of theblood vessel, then widens together with the end of the blood vessel, andfinally both are turned over around the end of the sleeve.

U.S. Pat. No. 2,779,996 describes an elastic ring as an auxiliary means,which is pushed into the interior of the protruding part of the vesselend. After being inserted, the ring—and thus also the protruding part ofthe vessel—is widened by means of compressed air, and in this way theprotruding part of the vessel end is turned over around the sleeve.

The device according to U.S. Pat. No. 3,040,748 is similar to theauxiliary devices in U.S. Pat. Nos. 2,940,452 and 3,180,337. It uses acylindrical piston with a conical end in a known manner. A thin tubularpiece made of an elastic material is pulled on behind the conical head.The rear end of this tube has a bead. It is held by a further tube whichcan be displaced in the axial direction, and is already widened. In aknown manner, the piston with the conical end is pushed into theprotruding part of the blood vessel and then pressed against the sleeve.This operation is assisted by a fluid which is pumped through the tip ofthe conical piston head into the clamped vessel. The fluid flows betweenthe vessel and the piston and also through the tubular piece made ofelastic material, and thus makes it easier to push the vessel end ontothe tubular piece. Once it has been pushed on, the flow of fluid isstopped. The outer, displaceable tube is then pushed in the direction ofthe sleeve. It takes with it the elastic tubular piece—and thus thevessel end pushed over the latter—and turns both of these over aroundthe sleeve.

U.S. Pat. No. 4,055,186 describes a press-fastening system for joiningtwo parts of an intestine. Attached to both parts of the press fasteneris a concentric ring which is mounted in a flexible manner in the axialdirection. The rings have an outer diameter which is somewhat smallerthan the inner diameter of the intestine parts to be connected. Thepress-fastener parts with the rings are pushed into the ends of theintestine parts and then the latter are turned over inwards around therings. There is no description as to how this is to be achieved. Thepress-fastener parts are then joined and latched together. Thanks to theflexible rings, the two intestine parts are pressed against one anotherwith a defined force.

U.S. Pat. No. 7,955,342 describes a device for connecting hollow organscomprising various elements that are held by holding devices. Saidholding devices can be laterally displaced on a slide rail, rotated ordetached and put on, and their position can be secured, if required. Thetraverse is used as a stop for the axial alignment of the holdingdevices. The holding devices carry clamping devices for retaining and,if required, clamping off the hollow organ ends. The holding devicescarry fittings. The two hollow organ ends to be connected are pushedthrough the fittings to such an extent as to project over the fittingends by a defined extend. The ends of the hollow organs are then turnedup by the ends of the fitting using two turn-up devices. The holdingdevice in the center holds an additional fitting into which the twofittings are inserted with the turned-up hollow organ ends and aresecured.

U.S. Patent Appl. Publ. No. 2010/0174300 A discloses a method forperforming end-to-end vessel anastomosis including providing a vesselsupport including a vessel receiving portion and a handle portionextending therefrom. The vessel receiving portion is an annulus. Thevessel receiving portion is positioned around the end of a first vesseland the end of the first vessel is everted about the outer diameter ofthe vessel receiving portion such that the inner surface of the vesselis directed outwardly. The end of the second vessel is positioned overthe everted end of the first vessel such that the inner surface of thesecond vessel is disposed against the inner surface of the first vessel.The ends of the vessel are secured either with a suture or a surgicaladhesive. The handle portion of the vessel support may be removed.

U.S. Patent Appl. Publ. No. 2005/0143758 discloses anastomosis devicesfor fixing a first conduit to a second conduit in an anastomosis, wherethe conduits are joined by interfacing their inner walls together. Theconduit which is loaded on the anastomosis device may be mounted in sucha way that the internal wall of the conduit does not make contact withthe anastomosis device.

U.S. Patent Appl. Publ. No. 2013/0012969 discloses a stent forconnecting adjacent tissues of the organs of a patient. The stentincludes a hollow cylindrical body which is formed by weaving asuperelastic shape-memory alloy wire in an overlapping manner such thatrhombic openings are formed, and wing parts which are provided byexpanding respective opposite ends of the hollow cylindrical bodyoutwards and turning the opposite ends inside out on bent portions. Thewing parts face each other so that the wing parts are tensed in alongitudinal direction of the cylindrical body. Thereby, the wing partscan elastically move inwards or outwards with respect to thelongitudinal direction to automatically adjust a distance between thewing parts in response to the distance between the adjacent tissues ofthe organs or thicknesses of walls of the organs, so that the wing partsare put into close contact with the adjacent tissues.

All the aforementioned devices for the anastomosis of blood vessels havecertain drawbacks with regard to handling or their function. The objectof the invention is therefore to find improved devices for anastomosiswithout the drawbacks of the prior art.

SUMMARY OF THE INVENTION

According to the invention, this object is achieved by a sleevecomprising the features according to claim 1, a fitting comprising thefeatures according to claim 13, a turning-over device for turning-overthe end of a hollow organ around the end of a sleeve comprising thefeatures according to claim 18 and a method comprising the featuresaccording to claim 28.

Further advantageous embodiments are described in the dependent claims.

The sleeve according to the invention is a sleeve for enforcing the endof a hollow organ so that it can be connected with a further end of ahollow organ. It comprises a cylindrical shape. The sleeve is configuredto be pushed over the end of the hollow organ and for turning-over theend of the hollow organ projecting from the sleeve around an end of thesleeve. The sleeve according to the invention has an adjustablediameter.

The sleeve according to the invention having an end of a hollow organfolded back over its end stabilizes and re-enforces the end of thehollow organ so that it can be brought in contact with another end of ahollow organ which has been prepared in the same way and can be fixed ina contact relation with the other hollow organ end by a fitting providedaround or grasping the sleeves with the two hollow organ ends secured tothem.

Due to its adjustable diameter the sleeve may be adjusted to differentouter diameters of hollow organs. Hence the sleeve is suitable for a usewith multiple hollow organs having different diameters.

According to one embodiment, the sleeve is formed by an expandablematerial mesh that is configured so that its diameter can be adjusted byapplying a pressure, particularly a radial pressure. The mesh can be aself-expandable material mesh that is formed by weaving filaments or bypunching or etching a material layer to form multiple filaments that areconnected with each other at nodes. According to a further embodiment,the sleeve is composed of fine metallic or non-metallic filaments.According to another embodiment the filaments have the shape of elongatemembers or wires, and the filaments may be fixedly secured to oneanother where the filaments intersect with one another. The filamentsmay be fixed to one another by welding. The filaments may have acylindrical, triangular, square, rectangular or hexagonal etc.cross-section. According to still another embodiment of the presentinvention the filaments may be thin bars which can have a square, orrectangular cross-section. Preferably, the filaments are fixedly securedto one another where the bars intersect with one another. The sleeve mayhave a rhomb-shaped or rectangle-shaped pattern of filaments in theunstressed state or under pressure.

According to yet a further embodiment, the sleeve is configured so thatit reduces its diameter or collapses by applying a radial pressure, andreturns to its original diameter when the pressure is released orreturns to a reduced diameter if a reduced pressure is exerted. Hence,the sleeve can be adjusted to hollow organs with different diameters.The adjustability of its diameter facilitates the positioning of thesleeve on the hollow organ, since it may be pushed on the hollow organwith a larger diameter, while the diameter of the sleeve can be adjustedto the outer diameter of the hollow organ by applying a correspondingradial pressure, once the sleeve is correctly positioned. When the endof the hollow organ is folded back on the sleeve it is kept at itsreduced diameter by the back-folded hollow organ end.

According to another embodiment the sleeve comprises a region having areduced diameter and at least one other region which comprises a largerdiameter. The shape of the sleeve may be preformed in this manner andconserves this geometry without any pressure being applied. The geometryfacilitates the pushing and positioning of the sleeve on the end of thehollow organ.

According to a further embodiment the sleeve has a constant diameterover its length without any pressure being applied and a region having areduced diameter when a radial pressure is exerted on the sleeve in thatrespective region, wherein at least one other region of the sleevecomprises a larger diameter when no pressure or a lower radial pressureis exerted on the sleeve.

According to a further embodiment the region having a reduced diameterincludes one end of the sleeve where a hollow organ end is folded backon the sleeve, wherein the pressure is exerted on the region of thesleeve by the folded back hollow organ end.

According to yet another embodiment the edge of the mesh can beconfigured so that the end of the hollow organ easily turns over thesleeve and remains there in a fixed position. In particular, the edge ofthe mesh at the end of the sleeve is sharp. The edge may also becontinuous. Furthermore, a section of the sleeve at at least one end ofthe sleeve may have a frustoconical shape, i.e. may have an increasingdiameter over a region at its end in order to support the folding backof the end of the hollow organ projecting from the sleeve.

According to another embodiment one or both ends of the sleeve areprovided with spikes radially extending from the sleeve, wherein thespikes are configured to fix the turned-over hollow organ endadditionally on the sleeve.

According to yet another embodiment the spikes extend from the sleeve atan angle between 5 degrees and 175 degrees with regard to thelongitudinal axis of the sleeve. In particular, the spikes may extendwith an angle from the group including 5, 10, 20, 30, 40, 50, 60, 70,80, 90, 100, 110, 120, 130, 140, 150, 160, 170, and 175 degrees or anangle in one of the ranges defined between the angles of the abovegroup.

According to a further embodiment the spikes are formed by filaments ofa material mesh forming the sleeve and extend from a region at the endof the sleeve.

According to a still another embodiment the spikes formed by filamentsof the material mesh are configured to vary their angle of extensionfrom the sleeve in dependence of the diameter of the sleeve. Inparticular, the filaments may be configured so that the angle ofextension of the spikes is at a minimum with regard to the longitudinalaxis of the sleeve when the sleeve has its maximum diameter, forexample, when no pressure is applied and the angle of extension of thespikes is at a maximum with regard to the longitudinal axis of thesleeve, when the sleeve has a larger diameter, for example, when apressure is applied that fits the diameter of the sleeve to the outerdiameter of the hollow organ. The minimum angle of extension of thespikes may by in a range between −10 and 10 degrees, in particular theangle can be zero degrees with regard to the longitudinal axis of thesleeve, or some other suitable angle, and the maximum angle of extensionof the spikes may by any angle of the group indicated above.

According to a further embodiment, the inner side of the sleeve foraccommodating the end of the hollow organ has a surface structure whichincreases the static friction when the hollow organ is pressed againstthe inner side of the sleeve but which at the same time does notsubstantially hinder the insertion of the hollow organ into a fitting.This surface structure may be achieved with spikes that can be similarto the spikes described above, wherein the spikes are oriented in adirection that permits to push the sleeve on the hollow organ buthinders a movement in the opposite direction. The spikes on the innersurface of the sleeve can be formed by some filaments of the mesh. Theangles indicated above with regard to the spikes that extend radiallyoutward from the sleeve are also applicable for the inner spikes.According to another embodiment the sleeve can also comprise a roughenedinner surface.

According to yet another embodiment, the sleeve for accommodating thehollow organ end has at least one groove or bead running around theentire outer circumference or inner circumference. In the case of asleeve that is formed by a material mesh, the groove or bead can beformed in the mesh. The groove or bead facilitates the holding of thesleeve in a fitting that accommodates for example two sleeves withhollow organ ends in a position in which the inner sides of the holloworgan ends are in contact with each other.

According to yet another embodiment the sleeve is formed of a stainlessmetal, steel, alloy, a biodegradable material, in particular, abiodegradable plastic, or a biocompatible material such as biocompatibleplastic, a memory shape alloy metal or a material comprising several ofthese properties or any other suitable material.

The invention also includes a fitting for receiving and fixing at leastone sleeve according to one of the embodiments described above that isconfigured to receive and hold two sleeves with turned-over hollow organends so that the inner sides of the hollow organ ends make contact withone another. The fitting supports the adhesion of the hollow organ ends.By means of the fitting, a re-connected and re-established hollow organmay be achieved. The fitting has a generally cylindrical shape.

According to an embodiment the fitting for accommodating the two sleevesis completely or partially slit in the longitudinal direction. Thisallows or facilitates the insertion of the two sleeves with the turnedover hollow organ ends.

According to yet another embodiment the fitting is a ring that iscompletely or partially slit in the longitudinal direction. According toa further embodiment the fitting comprises a fenestration that permitsto observe the ends of the hollow organs introduced into the fitting.Alternatively, the fitting may be formed of a transparent material, i.e.transparent plastic or biocompatible or biodegradable transparentplastic that permits the observation of the hollow organ endsencompassed and covered by the fitting.

According to still another embodiment the fit of the sleeve foraccommodating the hollow organ end and of the fitting for accommodatingtwo sleeves allows a press fit, an interference fit or a push fit.

According to still another embodiment the fitting comprises a curvedprofile or a U-profile along its longitudinal axis which permits thefitting to encompass two sleeves with turned-over hollow organ endspreferably over their entire lengths, wherein the inner sides of thehollow organ ends make contact with one another. The fitting may haveannular end walls at its ends that extend substantially perpendicular tothe longitudinal axis of extension of the fitting. The end wallscomprise a diameter that is smaller than the inner diameter of thefitting so that the end walls can contribute to hold a sleeve in thefitting. According to an embodiment the fitting has a length thatcorresponds to about the double length of a sleeve so that the fittingcan accommodate two sleeves with back folded hollow organ ends.

According to an embodiment, the fitting may be formed of metal orplastic material. In particular, the fitting may be formed of abiodegradable plastic or of biocompatible plastic or may be formed ofmagnesium that is covered by a biodegradable plastic.

According to yet another embodiment, the fitting for accommodating thetwo sleeves is split in the center, wherein the two parts are connectedvia an axially flexible central part so that, after the latching-in ofthe sleeves, a defined force is exerted on the turned-over hollow organ.

According to another embodiment, the fitting for accommodating twosleeves has at least one, but preferable two beads or grooves runningaround the entire inner circumference into which corresponding groovesor beads of the sleeves can latch. The grooves or beads may alsopartially extend around the inner circumference of the fitting.

According to the invention, a turning-over device is provided forturning over the end of a hollow organ around the end of a sleeve,wherein said turning-over device comprises a front part consisting of apin having a diameter which corresponds approximately to the innerdiameter of the hollow organ and a rear part having a diameter which islarger than that of the front part, wherein the rear part comprises afluid connection to at least one outlet of the device for a fluid thatduring the turning-over process is pressed out of said outlet, whereinsaid outlet is formed in a sidewall of said pin, wherein the fluid ispressed out of said pin at least partly under a nonzero angle inrelation to the axis of extension of said pin.

It is one of the benefits of the turning-over device of the inventionthat it permits to turn over the end of a hollow organ, in particular, ablood vessel around the end of a sleeve in a fast and reliable manner.The turning-over device of the invention can be used for turning overthe end of two related sections of hollow organs, in particular, bloodvessels, in order to subsequently bring them into contact with eachother to re-establish the hollow organ, in particular, blood vessel.

According to one embodiment, the pin of the device comprises anessentially rotationally symmetrical body, and the outlet is formed in asidewall of said rotationally symmetrical body. Such a shape of the pinprovides for an easy insertion of the front part of the turning-overdevice into the hollow organ. The tip of the pin may also be rounded.Since the outlet is formed in a sidewall of the pin, a stream ofpressurized fluid may be directed on the inner wall of the end of thehollow organ in order to support the turning-over of the hollow organend on a sleeve arranged on the hollow organ.

According to another embodiment, the outlet has the shape of a slit thatextends perpendicularly to the axis of symmetry of said pin over morethan half of its periphery. Preferably, the outlet extends over theentire periphery of the pin, so that an annular outlet is formed throughwhich pressurized fluid can be output homogenously on the entireinternal periphery of the end of the hollow organ in order to facilitateand effect the turning-over process. In accordance with the annularshape of the outlet, the ejected jet of fluid may have a circular shapeas well. According to yet another embodiment, the annular outlet can beinterrupted by solid sections or bars in the pin resulting in severalslit shaped outlet sections arranged around the periphery of the pinalong a circle.

According to another embodiment, the pin comprises several outletsdistributed over its surface wherein at least one, several or alloutlets are configured in a way so that a fluid is pressed out of the atleast one outlet, the several outlets under a non-zero angle in relationto the axis of symmetry of the pin.

The outlets may be distributed equally over the pin, particularly, in acircular section of the pin, or they can be located in two or moreopposite sections on the pin or also in a single section on one side ofthe pin or can be located in a larger number of sections on the pin.Additionally, an outlet may be provided in the tip of the pin from whichthe pressurized fluid is ejected essentially in the direction of thelongitudinal axis of the pin. The shape of the outlets may be circular,oval or rectangular. Furthermore, outlets with different diameters maybe combined on one pin. Also, the width of an outlet that has the shapeof a slit may vary over the pin. For example, the width of an annularslit may be larger at two opposite sections of the pin, while it issmaller at the two opposing sections between the opposing sections withthe larger slit width. Also a combination of outlets with differentshapes or sizes may be provided on the pin.

According to a further embodiment, the device is configured so that themean angle, at which the fluid exits from the at least one outlet withrelation to the longitudinal axis of extension of said pin is between 10and 90 degrees. The angle under which the pressurized fluid exits theoutlet may depend on the shape and the orientation of the conduits inthe pin for supplying the pressurized fluid to the at least one outlet.Specific angles under which the fluid may exit the at least one outletinclude 10, 20, 30, 40, 50, 60, 70, 80 and 90 degrees or any angles orranges between these angles. The diameter of the conduits may beconstant over the length of the conduits or may vary. The device mayinclude one or several conduits having a conical shape at least in asection of their length. The conical shape may have a pressurizingeffect on the fluid.

According to yet another embodiment, the at least one outlet ispositioned at a predetermined distance along the length of the pin,wherein the pin is configured to be pushed into the opening of thehollow organ so that the at least one outlet is covered by the holloworgan when the edge of the hollow organ is pushed over the pin towardsthe rear part of the device. The distance between the outlet in the pinand the beginning of the rear part of the device may approximatelycorrespond to the maximum length of the hollow organ end that can beturned over and folded back on the sleeve.

According to a further embodiment, the position of the at least oneoutlet is provided at a pre-determined distance from the distal end ofthe pin which defines the distance along which the hollow organ can beclamped between the pin and the sleeve that has been pushed over thehollow organ up to about the outlet in the pin. Since the outer diameterof the pin basically corresponds to the inner diameter of the holloworgan and a sleeve has been provided on the hollow organ in a section ofthe pin between the tip of the pin and the at least one outlet, thehollow organ can be fixed between the pin and the sleeve, in particular,due to friction between these elements. Preferably, the pin is insertedinto the hollow organ at most to a position where the outlet in the pinis not covered by the sleeve on the hollow organ so that the end of thehollow organ can be turned over and folded on the sleeve by thepressurized fluid exiting the outlet.

According to still another embodiment, the pin comprises a centralconduit that essentially extends in its longitudinal direction toconnect the front part of the device with its rear part wherein thecentral conduit branches off in at least on branch conduit that isconnected with the at least one outlet.

According to another embodiment, the branch conduit branches off fromthe central conduit in direction of the distal end of the pin with anangle between 10 and 90 degrees in relation to the longitudinal axis ofthe pin. Due to the tilted arrangement of the branch conduit in the pin,the exit of pressurized fluid with a defined angle in relation to thelongitudinal axis of the pin can be achieved so that the fluid directlystrikes the inner wall of the hollow organ end in order to turn it over.Specific angles of the branch conduit in relation with the pin axisinclude 10, 20, 30, 40, 50, 60, 70, 80, 90 degrees, or any angles orranges between these angles.

According to an embodiment the central conduit and the branch conduitcomprise a straight shape. However, curved shapes for one or severalconduits may also be conceived. Furthermore, in case the pin includesseveral outlets, separate branch conduits may be provided connecting thecentral conduit with the individual outlets. The device may even includeseveral central conduits.

According to a further embodiment, the front side of the rear part ofthe device facing towards the opening of the hollow organ has a concavepart. The concave part can be provided as an extension at the proximalend of the pin and may comprise a rotational symmetry around thelongitudinal axis of the pin. The concave part facilitates theturning-over of the end of the hollow organ and may also widen the endof the hollow organ when the pin is pushed in the hollow organ.

According to another embodiment the concave part may have a U-shapedcross-section. At the side opposing the pin the concave part may extendas a wall that extends parallel to the pin, wherein an annular groove isformed between the wall and the pin. The concave part may have asemicircular cross-section. The depth of the groove may correspond tothe radius of the semicircular cross-section of the concave part.However, the ratio between the depth of the groove and the radius of thesemicircular cross-sectional profile of the concave part may also have afactor of 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, a value in a rangebetween these numbers or a larger value. The depth of the groove may bein a range between 2 and 8 mm depending on the diameter of the holloworgan or blood vessel.

According to an embodiment one or several outlets for pressurized fluidmay be provided in the concave part. An outlet may be provided thatcomprises an annular shape that may be centralized with regard to theaxis of symmetry of the pin. According to another embodiment severaloutlets may be arranged on a circular line around the axis of symmetryof the pin.

According to still another embodiment, the rear part of the devicecomprises a reservoir for the fluid, wherein said rear part has anopening through which said fluid in said reservoir can be pressurized. Ameans for pressuring the fluid in the reservoir can be a syringe, acatheter or a pump connected to the opening in the rear part.

According to the invention, a method of connecting two hollow organswith a sleeve and a device according to the invention as described aboveis provided, wherein the method comprises steps of pushing the sleeveover the end of the first hollow organ so that a pre-determined lengthof the hollow organ projects from the sleeve, pushing the device forturning over the end of the hollow organ around the end of the sleevewith its front part into the opening of the hollow organ until the endof the hollow organ surrounds the pin of the front part and covers theoutlet; pressing a fluid through the outlet in the pin under a non-zeroangle in relation to the longitudinal axis of the pin on the inner wallof the end of the hollow organ, wherein said pressurized fluid exitingfrom the outlet strikes the hollow organ and turns over the end of thehollow organ over the sleeve.

The method according to the invention facilitates the generallydifficult task of turning over a hollow organ such as a blood vesselover a sleeve in order to connect two ends of hollow organs at theirinner sides in order to re-establish the closed hollow organ.

According to another embodiment, the two ends of hollow organs providedwith sleeves each having turned-over hollow organ ends are introducedinto a common fitting so that the ends of the hollow organs make contactwith another and the hollow organ ends are fixed in the fitting. With afitting that is slit in the longitudinal direction, the insertion of thetwo sleeves can easily be provided.

When using a sleeve with an adjustable diameter such as a sleeve formedof a self-expandable mesh, the diameter of the sleeve can be exactlyadjusted to the outer diameter of the hollow organ so that a stable andstrong connection of the hollow organ end, which is folded over on thesleeve, can be achieved.

According to yet another embodiment, the method comprises clamping offthe hollow organ behind the sleeve before the pressurized fluid exitsthe outlet and until the end of the hollow organ has been turned overaround the end of the sleeve. Clamping off the hollow organ has theeffect that pressurized fluid which enters the hollow organ through theoutlet in the pin increases the pressure in the hollow organ so that thefriction between the hollow organ and the sleeve is increased in orderto facilitate the turning-over of the hollow organ end and to avoid apushing-back of the hollow organ from the sleeve and the device due tothe pressure of the pressurized fluid.

BRIEF DESCRIPTION OF THE DRAWINGS

Further embodiments and advantages of the invention will become apparentfrom the following description of preferred embodiments of the inventionwith reference to the drawings, wherein:

FIGS. 1 a, 1 b show a sleeve for enforcing the end of a hollow organaccording to one embodiment of the invention;

FIG. 2a, 2b show a sleeve for enforcing the end of a hollow organaccording to another embodiment of the invention;

FIG. 2c shows a sleeve having spikes radially extending from the sleeve,according to one embodiment of the invention.

FIGS. 3a-d show a fitting according to one embodiment of the inventionin (a) a first open state, (b) arranged around two hollow organ endsprovided with sleeves in an open state, (c) in a closed state and (d)arranged around two hollow organ ends in a closed state; and

FIG. 4 shows a turning-over device, according to one embodiment of theinvention, in a state at which the pin of the front part of theturning-over device is inserted in the hollow organ and the end of theblood vessel butts against the rear part of the turning-over device;

FIG. 5 shows the turning-over device of FIG. 4 in a state when the endof the hollow organ is completely folded back on the sleeve;

FIG. 6 shows the turning-over device and the hollow organ with the endof the hollow organ folded back on a sleeve according to an embodimentof the invention;

FIG. 7 shows a sequence of steps of connecting two hollow organ ends;

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1a and 1b and FIGS. 2a and 2b show sleeves 19 according to aparticular embodiment of the invention. The sleeves 19 comprise acylindrical shape and are formed of a material mesh comprising ashape-memory alloy material. The sleeves 19 have an adjustable diameter.FIGS. 1a and 2a show the mesh structure of the sleeve 19 in a compressedstate when a pressure, in particular a radial pressure is exerted on thesleeve 19 as, for example, by forceps and FIGS. 1b and 2b show the meshstructure of the sleeve 19 in an expanded state without any pressure ora reduces pressure exerted. The sleeves 19 can be formed of ashape-memory allow material, such as Nitinol, of stainless steel or of abiodegradable material. Releasing the pressure exerted on the sleeves 19in FIGS. 1a and 2 a, the sleeves expands to a larger diameter as isshown in FIGS. 1b and 2 b. The sleeve 19 shown in FIGS. 1a and 1b isformed of fine filaments having a cylindrical cross-section, wherein thefilaments are connected with each other at the crossing points bywelding. The sleeve 19 comprises a rhomb shaped mesh pattern. The sleeve19 shown in FIGS. 2a and 2b is formed of bar-shaped filaments having aflat rectangular cross-section. The sleeve 19 has a rectangular meshpattern as is visible in FIG. 2a . The sleeve 19 may be formed bypunching or etching a thin material layer of a suitable material such asstainless steel, Nitinol, gold, etc. Alternatively, the sleeve 19 may beformed by welding of filaments.

FIG. 2c shows sleeve 19 having spikes 22 radially extending from one endof sleeve 19, according to one embodiment of the invention. One or bothends of the sleeve may be provided with spikes 22 radially extendingfrom the sleeve 19, wherein the spikes 22 are configured to fix theturned-over hollow organ 5 end additionally on the sleeve 19. The spikes22 can extend from the sleeve 19 at an angle between 5 degrees and 175degrees with regard to the longitudinal axis of the sleeve 19. Accordingto a further embodiment, as shown in FIG. 2c , the spikes 22 are formedby filaments of a material mesh forming the sleeve and extend from aregion at the end of the sleeve. According to a still anotherembodiment, the spikes 22 formed by filaments of the material mesh areconfigured to vary their angle of extension from the sleeve independence of the diameter of the sleeve 19. In particular, thefilaments may be configured so that the angle of extension of the spikes22 is at a minimum with regard to the longitudinal axis of the sleeve 19when the sleeve 19 has its maximum diameter, for example, when nopressure is applied, and so that the angle of extension of the spikes isat a maximum with regard to the longitudinal axis of the sleeve 19, whenthe sleeve 19 has a larger diameter, for example, when a pressure isapplied that fits the diameter of the sleeve 19 to the outer diameter ofthe hollow organ.

FIG. 3 shows a fitting 13 according to a particular embodiment of theinvention. The fitting 13 is formed by a flat ring having a slit in thelongitudinal direction so that it can be bend and opened as is visiblein FIG. 3a in order to fix it around two hollow organ 5 ends providedwith sleeves 9 as shown in FIG. 3b . In the fitting 13, a number ofwindows 23 or openings are provided that permit to observe the contactbetween the hollow organ 5 ends. By closing the fitting 13 on theconnected hollow organ 5 ends as is shown in FIG. 3d , a stableconnection of the hollow organ 5 ends is achieved. As is visible in FIG.3c , the fitting 13 can be formed of a spring material that can beopened against its spring tension and automatically closes on theconnected hollow organ 5 ends when the bending force is released. Thefitting 13 may also be formed by a biodegradable or biocompatibleplastic material. In particular, it may be formed by magnesium coveredwith biodegradable plastic. The fitting 13 may also be formed by metalor any other suitable material.

FIG. 4 shows the turning-over device according to one embodiment of theinvention, wherein a pin 1 of a front part 3 of the turning-over deviceis inserted into a hollow organ 5 so that the end of the hollow organ 5abuts against a concave part of a rear part 4 of the turning-over devicefrom which the pin 1 of the front part 3 projects. The pin 1 comprisesan annular outlet 7 provided in the pin 1 perpendicular to itslongitudinal axis of extension. Furthermore, a central conduit 9coinciding with the longitudinal axis of symmetry of the pin 1 isprovided in the pin 1 which branches off into a branch conduit 11 thatends in the annular outlet 7 . The branch conduit 11 branches off fromthe central conduit 9 at an angle of about 50 degrees. While the centralconduit 9 traverses basically the entire pin 1 and terminates in a deadend, the branch conduit 11 branches off from the central conduit 9 atapproximately half of its length. Furthermore, in the rear part 4 of theturning-over device, a reservoir 15 is provided which is connected tothe central conduit 9. The reservoir 15 is configured to receive a fluidthat can be pressurized and ejected through the outlet 7. In order topressurize the fluid, the reservoir 15 comprises a channel 16 with anopening to the outside of the rear part 4. A means for pressurizing afluid in the reservoir 15 such as a syringe 17 or a catheter may beconnected to the channel 16. Preferably, the fluid used in theturning-over device is a biocompatible fluid such as a saline solution.Furthermore, as is visible in FIG. 4, a sleeve 19 has been pushed overthe end of the hollow organ 5 in such a way that the sleeve 19 partlyoverlaps with the tip of the pin 1 but does not cover its outlet 7. Theend of the hollow organ 5 is arranged between the sleeve 19 and the pin1 so that it extends over the entire length of the pin 1 up to theconcave part 3 of the rear part 4 of the turning-over device.

Pressurizing the fluid in the reservoir 15 with a pressurizing meanscauses the fluid to exit the annular outlet 7. The jet of pressurizedfluid impinges on the inner side of the hollow organ 5 along a basicallycircular line and turns the end of the hollow organ 5 over the end ofthe sleeve 19 so that the end of the hollow organ 5 is folded back onthe sleeve 9 as is shown in FIG. 5. Preferably, the diameter of thesleeve 19 approximately corresponds to the outer diameter of the holloworgan 5, while the outer diameter of the pin 1 approximately correspondsto the inner diameter of the hollow organ 5.

FIG. 6 shows the turning-over device in combination with a sleeve 19according to a particular embodiment that has an adjustable diameter. Asis visible in FIG. 4, the sleeve 19 consists of a mesh of filaments of aself-expandable material. By means of a clamping device 21 (e.g.forceps) exerting a radial pressure on the sleeve 19, the diameter ofthe sleeve, which has been pushed over the hollow organ 5, is reducedand adjusted to the outer diameter of the hollow organ 5. As is visiblein FIG. 6, the diameter of the sleeve 19 is only adjusted in section Aon the left side of the sleeve 19, while the diameter of the sleeve 19on the right side in section B which has not been compressed issignificantly larger and corresponds to the unrestricted diameter of themesh. Accordingly, the sleeve 19 formed of a self-expandable materialmesh can be adjusted exactly to the diameter of the hollow organ 5, andsubsequently the end of the hollow organ 5 can be turned over with theturning-over device and folded back on the sleeve 19. Once the end ofthe hollow organ 5 is turned over on the sleeve, the pressure exerted bythe clamping device 21 can be released and the sleeve 19 will be held inthe compressed shape by the back-folded hollow organ 5 end.

FIG. 7 schematically shows the procedural steps of connecting two holloworgan 5 ends according to one example. In a first step 1, a sleeve 19 ispushed over the hollow organ 5 end, wherein a defined length of thehollow organ 5 end projects from the sleeve 19. The sleeve 19 may be asleeve 19 with a fixed diameter or a sleeve 19 having an adjustablediameter, wherein the sleeve 19 is preferably uncompressed during thepositioning on the hollow organ 5. As shown in step 2, the length of thehollow organ 5 end projecting from the sleeve 3 basically corresponds tothe distance between the proximal end of the pin 1 and the outlet 7provided in the pin 1, wherein the sleeve 19 does not overlap the outlet7 but just the portion of the pin at its distal end. Furthermore, aclamp 20 is provided on the hollow organ 5 behind the sleeve 19.Subsequently, a biocompatible fluid such as a saline solution ispressurized by means of a syringe 17, is ejected from the outlet 7 ofthe pin 1 and turns over the end of the hollow organ 5 so that it isfolded back on the sleeve 19 as is visible in step 3. Subsequently, asecond hollow organ 5 end is prepared in the same manner as shown instep 4. In step 5, the two hollow organ 5 ends folded back on respectivesleeves 9 are introduced into a common fitting 13 and latched therein.In the fitting 13, the inner sides of the hollow organ 5 ends get intocontact with each other and are fixed in this position. Accordingly, are-established hollow organ 5 such as a blood vessel is provided.

Numerous modifications may be provided to the shown embodiments withoutdeparting from the scope of the invention.

1. A turning-over device for turning-over the end of a hollow organ (5)around the end of a sleeve (19) according to claim 1, comprising a frontpart (3) consisting of a pin (1) having a diameter which correspondsapproximately to the inner diameter of the hollow organ (5), and a rearpart (4) having a diameter which is larger than that of the front part(3), wherein the rear part (4) comprises a fluid connection to at leastone outlet (7) of the device for a fluid that during the turning-overprocess is pressed out of said outlet (7), and wherein said outlet (7)is formed in a sidewall of said pin (2), and wherein the fluid ispressed out of said pin (2) at least partly under a nonzero angle inrelation to the axis of extension of said pin (1).
 2. The deviceaccording to claim 18, wherein said pin (1) comprises an essentiallyrotationally symmetrical body, and wherein said outlet (7) is formed ina wall of said rotationally symmetrical body.
 3. The device according toclaim 18, wherein the outlet (7) comprises an annular shape and in thatit extends perpendicularly to the axis of symmetry of said pin (1) overmore than half of its periphery.
 4. The device according to claim 18,wherein the device is configured so that the mean angle at which thefluid exits the at least one outlet (7) with relation to thelongitudinal axis of extension of said pin (1) is between 10 and 90degrees, including 10, 20, 30, 40, 50, 60, 70, 80 or 90 degrees.
 5. Thedevice according to claim 18, wherein the at least one outlet (7) ispositioned at a predetermined distance along the length of the pin (1),and wherein the pin (1) is configured to be pushed into the opening ofthe hollow organ (5) so that the at least one outlet (7) is covered bythe hollow organ (5) when the edge of the hollow organ (5) is pushedover the pin (1) towards the rear part (4) of the device.
 6. The deviceaccording to claim 18, wherein the position of said at least one outlet(7) is spaced from the distal end of the pin (1) by a predetermineddistance along which the hollow organ (5) can be clamped between the pin(1) and the sleeve (19) that has been pushed over the hollow organ (5).7. The device according to any claim 18, wherein the pin (1) comprises acentral conduit (9) that essentially extends in its longitudinaldirection to connect the front part (3) of the device with its rear part(4), and wherein said central conduit (9) branches off in at least onebranch conduit (11) that is connected with the at least one outlet (7).8. The device according to claim 24, wherein said branch conduitbranches off from said central conduit (9) in direction of the distalend of the pin (1) with an angle between 10 and 90 degrees.
 9. Thedevice according to claim 18, wherein the front side of the rear part(4) of said device facing towards the opening of the hollow organ (5)has a concave part.
 10. The device according to claim 18, wherein therear part (4) of said device comprises a reservoir (15) for the fluid,and wherein said rear part (4) has an opening through which said fluidin said reservoir (15) can be pressurized.